Catheter Ablation for Atrial Fibrillation and Heart Failure

Recruitment & Eligibility

Inclusion Criteria

Age 18 years to 80 years
Clinical diagnosis of CHF based on symptoms (Shortness of breath, fatigue, peripheral edema)
Systolic left ventricular dysfunction with ejection fraction 40% or less
NYHA Class I, II or III heart failure
Paroxysmal AF(2 or more episodes in one month) that terminate within 7 days:or persistent AF (more than 7 days or less than 7 days but terminated with pharmacologic or electrical cardioversion).
Willing and able to sign informed consent

Exclusion Criteria

Previous ablation
Left atrial size greater than 60mm(parasternal view on transthoracic echocardiogram)
AF episodes triggered by another uniform arrhythmia(e.g.atrial flutter or atrial tachycardia)
Active alcohol or drug abuse, which may be causative of AF
Severe valvular disease requiring surgical repair
Myocardial infarction within 6 months of enrollment
Abnormality that prevents catheter introduction
Coronary surgical revascularization or other cardiac surgery within 6 months of enrollment
Patients in whom heart transplant expected with 6 months
AF deemed secondary to a transient or correctable cause (e.g.electrolyte imbalance ,trauma,recent surgery,,infection, toxic ingestion or endocrinopathy
Pregnancy or women of child bearing potential & not on reliable method of birth control
Contraindication to Warfarin therapy or other bleeding diathesis
Participation in another clinical trial
Inaccessable to follow-up
Life expectancy of less than 24 months caused by reasons other than heart disease
Renal failure requiring dialysis
Decompensated CHF within 48 Hours of enrollment
Second or third degree AV block or sinus pause greater than 3 seconds, resting heart rate less 30 bpm without a permanent pacemaker
A history of drug induced Torsades de Pointes or congenital long QT syndrome
Currently responding to antiarrhythmic drug therapy
Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for 24 hours or longer.
Unwilling or unable to sign informed consent

Study & Design

Arm && Interventions

Group	Intervention	Description
Optimal Medical therapy	Pulmonary Vein Isolation (PVI)	Subjects with Class I,IIor III congestive heart failure on optimal medical therapy. Planned catheter ablation for paroxysmal or persistent atrial fibrillation. Paroxysmal AF defined as recurrent AF(2 or more episodes in one month) that terminate within seven days. Persistent AF defined as sustained beyond seven days, or lasting less than seven days but requiring pharmacologic or electrical cardioversion.

Primary Outcome Measures

Name	Time	Method
Improvement in LVESV by 15% or more from baseline at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram	6 months
NYHA Class	6 months
Quality of Life	6 months
Six minute hall walk test	6 months
Hospitalization for HF	one year	Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality
Absence of Atrial fibrillation	one year

Recruitment & Eligibility